12 results
The purpose of the study is to investigate the maximum effect of ADASUVE on repolarization of the heart. This is the process where the cells of the heart muscle recharge again after contraction. If this process is strongly slowed down, (potentially…
Primary Objective: The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose of 600 and 800 mg MFX. Secondary Objectives: * To evaluate limited…
The purpose of part A of the study is to investigate how safe the study drug is and how well the study drug is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body. The…
The primary objective is to compare the efficacy of moxifloxacin 400 mg PO OD for five days with the respective efficacy of amoxicillin clavulanic acid 875/125 mg PO BID for seven days in the treatment of subjects with AECB. The primary efficacy…
The primary objective of the study is to reject the Null hypothesis: A 7 to 21 day therapy with moxifloxacin, 400 mg once daily is more than 10 % less effective than a 7 to 21 day therapy with piperacillin/tazobactam three times daily possibly…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
The purpose of the study is to investigate the effect of CBD on specific ECG parameters. Importantly, it will be evaluated if there is a prolongation of the QT interval. When the QT interval is prolonged, repolarization of the heart is delayed. This…
The primary objectives1. To assess the safety and tolerability of intravenous tracer administration of ANXV-800CW in up to three doses (0.5 mg, 1.0 mg, 2.0 mg flat dose) in patients with RVO and/or DR2. To determine the feasibility of molecular…
A relatively new method to determine margin distance is intraoral resection with a small Ultrasound (US)-probe. US is already used to determine tumor-thickness in tongue cancer preoperatively, because of its high predictive value. Four previous…
The aim of this research is to decrease the number of involved margins, resulting in less adjuvant therapy and less local recurrences.
Primary Objective:To evaluate the efficacy potential, safety and tolerability of intravenously administered ANXV, in ascending doses, and two different dosing regimens, in patients with confirmed moderate to severe COVID-19.Secondary Objectives:To…
In last decades, ultrasound probes have become smaller, which made adequate intraoral ultrasound of oral tumors possible. Therefore, invasion depth is now determined pre-operatively by intraoral ultrasound for staging of oral cancer. Our feasibility…